Trial record 3 of 701 for:    Open Studies | narcotics

Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Masonic Cancer Center, University of Minnesota
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01705288
First received: October 9, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

Over 600,000 hysterectomies are performed annually in the United States. Despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.


Condition Intervention Phase
Cervical Cancer
Uterine Endometrial Cancer
Ovarian Cancer
Procedure: Laparotomy
Drug: intravenous narcotics
Drug: standard anesthesia
Drug: regional anesthesia
Drug: Non-steroidal anti-inflammatory drugs
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Return to Function [ Time Frame: 1 Months ] [ Designated as safety issue: No ]
    The primary outcome of this study is a reduction of length of hospital stay from a mean of 5 days to 3 days.


Secondary Outcome Measures:
  • Comparison of Pain Assessment [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]
    Secondary outcome is to determine if rapid recovery can improve Visual Analogue Scale (VAS) for pain assessment. VAS scales are a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. VAS score is determined by measuring the distance (mm) from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 mm.

  • Comparison of Pain Medications Used [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]
    Another secondary outcome will be whether the rapid recovery protocol decreases the amount of narcotic pain medication used by patients during their hospital stay.


Other Outcome Measures:
  • Comparison of Anti-Emetics Use [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]
  • Comparison of Rates of Readmission to Hospital [ Time Frame: Month 1 ] [ Designated as safety issue: Yes ]
  • Comparison of Complications During Readmission [ Time Frame: Month 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group (Standard Laparotomy)
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Procedure: Laparotomy
Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital
Drug: intravenous narcotics
given for pain management after surgery per physician orders
Other Name: morphine
Drug: standard anesthesia
inhalant or intravenous during surgery
Other Name: general anesthesia
Experimental: Rapid Recovery Group
Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.
Procedure: Laparotomy
Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital
Drug: regional anesthesia
given by spinal or epidural infusion
Other Name: local anesthesia
Drug: Non-steroidal anti-inflammatory drugs
given for pain management after surgery
Other Name: NSAIDs

Detailed Description:

Subjects will be randomly assigned to one of two groups: Rapid recovery protocol (regional anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs (NSAIDS) over narcotic pain medications, early ambulation, and early enteral feeding) or standard of care (traditional laparatomy and supportive care).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who are being seen at the Women's Health Center by the Gynecologic Oncology group at the University of Minnesota if planned surgery includes an exploratory laparotomy

Exclusion Criteria:

  • < 19 years old
  • Pregnant
  • Undergoing a procedure other than laparotomy
  • Scheduled to be discharged the same day of surgery
  • Chronic narcotic pain medication user
  • American Society of Anesthesiologists (ASA) score of > or = 3
  • Any condition that would exclude women from undergoing regional anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705288

Contacts
Contact: Peter Argenta, M.D. 612-626-3111 argenta@umn.edu

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Peter Argenta, M.D.    612-626-3111    argenta@umn.edu   
Principal Investigator: Peter Argenta, M.D.         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Peter Argenta, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01705288     History of Changes
Other Study ID Numbers: 2012LS096
Study First Received: October 9, 2012
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
laparotomy
hysterectomy

Additional relevant MeSH terms:
Narcotics
Endometrial Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Anesthetics
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 31, 2014